510(k) · Cleared
ClearedDigiarc 100AU+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing East Whale Imaging Technology Co., Ltd. · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Jul 31, 2014 as substantially equivalent to K131423 (Beijing East Whale Imaging Technology Co., Ltd., 2013) after a 38-day review. Its family tree reaches back 6 generations to 2002. 2 of the 13 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Jul 31, 2014
- Review
- 38 days
- Class
- Class II
- Product code
- OXO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K021049 (2002). 8 ancestors in all, the oldest K911739 (1991). 4 later devices descend from it, 1 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK021049 Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Recalled (Class I)
- 5 generations backK041932 Oec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc. · 2004 · Recalled
- 4 generations backK073543 Oec 9900 EliteGe Oec Medical Systems · 2008 · Recalled
- 3 generations backK082781 Oec 9900 EliteGe Healthcare Surgery · 2009 · Recalled
- 2 generations backK120613 Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · Recalled
- 1 generation backK131423 G-Arm Multiscan SystemBeijing East Whale Imaging Technology Co., Ltd. · 2013
- This deviceK141672 Digiarc 100AU+Beijing East Whale Imaging Technology Co., Ltd. · 2014
- Descendant · cites it directly · 3 of its ownK151280 MultiScan G-Arm SystemBeijing East Whale Imaging Technology Co., Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK160984 MultiScan G-Arm SystemBeijing East Whale Imaging Technology Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK251004 Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)Hefei Chimed Intelligent Machine Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK163429 B6Beijing East Whale Imaging Technology Co., Ltd. · 2017
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K151280MultiScan G-Arm SystemBeijing East Whale Imaging Technology Co., Ltd. · 2015 · cites it directly3descendants
- K160984MultiScan G-Arm SystemBeijing East Whale Imaging Technology Co., Ltd. · 2016 · 2 generations on1descendant
- K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)Hefei Chimed Intelligent Machine Co., Ltd. · 2025 · 2 generations on0descendants
- K163429B6Beijing East Whale Imaging Technology Co., Ltd. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K021049 | Oec 9800 Plus Digital Mobile Imaging System | Ge Oec Medical Systems | 2002 | Class I |
| −5 | K041932 | Oec Olympus Fluoroscopic Imaging System | Ge Oec Medical Systems, Inc. | 2004 | 7 |
| −4 | K073543 | Oec 9900 Elite | Ge Oec Medical Systems | 2008 | 5 |
| −3 | K082781 | Oec 9900 Elite | Ge Healthcare Surgery | 2009 | 4 |
| −2 | K120613 | Oec 9900 Elite | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012 | 7 |
| −1 | K131423 | G-Arm Multiscan System | Beijing East Whale Imaging Technology Co., Ltd. | 2013 | — |
| 0 (this device) | K141672 | Digiarc 100AU+ | Beijing East Whale Imaging Technology Co., Ltd. | 2014 | — |
| +1 | K151280 | MultiScan G-Arm System | Beijing East Whale Imaging Technology Co., Ltd. | 2015 | — |
| +2 | K160984 | MultiScan G-Arm System | Beijing East Whale Imaging Technology Co., Ltd. | 2016 | — |
| +2 | K251004 | Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) | Hefei Chimed Intelligent Machine Co., Ltd. | 2025 | — |
| +3 | K163429 | B6 | Beijing East Whale Imaging Technology Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2003 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OXO device
- #1 K253296 Digital C-ARM with 3Dscore 15.1 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K131423 | G-Arm Multiscan SystemSummary page 2…WHALeF 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)] 510(k) Number K131423 Applicant Beijing East Whale Imaging Technology Co., Ltd. Device Name G… | 2013 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151280 | MultiScan G-Arm System | 2015 | 3 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K024012Oec 9800 E/CV+ Digital Mobile Imaging SystemGe Oec Medical Systems · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 6 of the 8 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K151280 (Beijing East Whale Imaging Technology Co., Ltd., 2015) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K131423.
How does its category compare?
All OXO devicesOXO Image-Intensified Fluoroscopic X-Ray System, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OXO
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OXO
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OXO
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OXO
118in 2025
MAUDE reports naming product code OXO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 48 | 4 | 5 |
| 2013 | 2 | — | 3 | 41 |
| 2014 | 2 | — | 4 | 89 |
| 2015 | 1 | — | 0 | 97 |
| 2016 | 3 | 128 | 3 | 3,820 |
| 2017 | 4 | 57 | 4 | 1,697 |
| 2018 | 1 | — | 11 | 1,647 |
| 2019 | 3 | 213 | 0 | 1,297 |
| 2020 | 0 | — | 0 | 816 |
| 2021 | 2 | — | 0 | 554 |
| 2022 | 0 | — | 0 | 295 |
| 2023 | 0 | — | 0 | 275 |
| 2024 | 2 | — | 4 | 192 |
| 2025 | 4 | 97 | 0 | 118 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The current modifications do not change the indications for use , as previously reported end cleared.
The DigiArc 100AU+ is a mobile digital X-ray G-Arm diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes; real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery, it is not intended to be used in interventional procedures. The DigiArc 100AU+ permits a quaflified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients at the age of at least eighteen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141672 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141672: Digiarc 100AU+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141672
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026